Statement on Issues to Be Considered Before New Surgical Technology is Applied to the Care of Patients

Online September 1, 1995

The following statement on issues surrounding the introduction
of new surgical technology was developed by the Committee on
Emerging Surgical Technology and Education of the American College
of Surgeons and approved by the College's Board of Regents at
its June 1995 meeting.

As major new biomedical technology is developed and made available
for use, its worth is measured on the basis of the value and
safety it confers for patients. Part of this process of evaluation
should include a comparison with existing and proven technologies
that deal with similar clinical problems. Indications for application
of the technology should be carefully defined and patients selected
using clear criteria. The qualifications of those who propose
to use the new technology must be carefully assessed, verifying
that the individual has had comprehensive education and experience
in the management of the disease process for which the technology
is applied, has acquired the necessary technical skills, and
is competent to recognize and manage any complications resulting
from use of the new technology. Questions that might be raised
by surgeons and health care institutions as a new technology
is introduced include the following:

1. Has the new technology been adequately tested for safety
and efficacy?

In consideration of this question, data are developed based
on careful, controlled clinical trials and observations. It may
be that the initial evaluation of complex and novel technologies
would be best accomplished in a few specialized centers where
expertise and support facilities are available. The results of
the trials should be published in peer-reviewed scientific literature
so that the medical community at large has the benefit of studying
the trial in detail before deciding to adopt and use the new
technology.

2. Is the new technology at least as safe and effective
as existing, proven techniques?

There is enormous public pressure brought to bear to reduce
the extent of invasive surgical procedures in favor of the use
of minimal access techniques. When assessing the new technology,
safety becomes a major consideration. Although attractive to
patients, some minimal access procedures may carry risks greater
than the established counterpart, even the risk of sudden death
or disability as, for example, might occur during performance
of endovascular procedures in major arteries. Newer procedures
may be less effective than their standard counterpart, and sometimes
the early benefits of lessened hospital stay or reduced postoperative
pain are outweighed by earlier recurrence of the disease process.
Only with careful clinical trials and published observations
can a conclusion be reached that the new technology is an acceptable
and effective substitute for an established alternative.

3. Is the individual proposing to perform the new procedure
fully qualified to do so?

Many skills are highly specialized. The mere acquisition of
a skill is not the only criterion by which to measure qualifications.
In order to determine and apply proper indications for a procedure
and to select the appropriate patients for application of the
technology, comprehensive knowledge of the disease process and
experience in management of patients with the disease is essential.
Prompt recognition and management of complications can only be
achieved when the individual or team member is fully qualified
in all aspects of treatment of the disease.

4. Is the new technology cost-effective?

"Cost-effectiveness" is a product of many factors:
the costs of developing and testing the new technology; the actual
costs of the equipment associated with the new technology; the
costs of the support services needed to safely provide the service;
the costs of educating health care professionals in the use of
the technique; the benefits of lessened hospital stay and period
of disability; and the likelihood of a good long-term outcome
and lower long-term health care costs. Each of these factors
must be taken into account when making a determination that the
new technology offers cost benefits when compared with alternatives,
either established treatments or nonsurgical options. It becomes
necessary to establish and maintain a database in which outcome
measures will include cost analyses.

Reprinted from Bulletin of the American College
of Surgeons
Vol. 80, No. 9, Pages 46-47, September 1995